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Let's talk for a moment on double-blinded testing.
I think it is all fake - I'll explain.

Some time ago, a friend who also has MS, started in a trial of a new drug, the pil.
She was on interferon before.
I asked her: are you not afraid that they will give you a placebo? And that you get worse?

Her reply was telling a lot.
The doctors monitored her heart rate after taking the new pil.
The heart rate dropped significantly, even to a point that she had to stay in the hospital over night.
The doctors were convinced that there was active substance in the pills.
Yet, the trials was 'sold' as double-blinded.

So what double-blinded?
It wasn't even single blinded.
I think this is true for many trials of medications.
And in fact the double-blinded testing ... is all a joke.

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I agree, it's not perfect, but it may be different too with a surgical procedure rather than a medication. I am not sure how the three studies I mentioned in the beginning are structured...I am going under the assumption that it will be carried off intelligently and patients will not known whether they had the venoplasty or not.

"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition

ikulo wrote:Even if the trial is set for a long duration, it may be ended early if the placebo group gets much worse. I've read about such results before.

This is true, but in most studies there is an intermediate analysis point where the statisticians look at the data and tell the researchers one of three things...(1) either to stop the trial early and offer the treatment to everyone, the end effect has already been established, or (2) keep on with the study, it may or may not find statistically significant results, or (3) stop the study, no matter how good the final group is, it will not be enough to establish statistical significance.

The timing of the intermediate review is generally set when the study is approved by the FDA or the IRB. I do not know if they ever do continuous, on-going statistical review so they would know exactly when the study has reached statistical significance but I doubt it. In most cases if nat all there will be an intermediate point, and this would be another consideration to the 6 CeCe listed. If they check after 6 months or after 2 years it would make a difference to deciding if you want to volunteer.

BTW, I too have PPMS, it has been very slow all my adult life, and I have participated in a number of studies, so I would be willing to participate in another. It is very important information to get. Especially in the U.S. where the government is going to be more and more involved in paying for treatment, they will not approve expensive treatment that has not been scientifically proven. Look at Britain.

Last edited by fogdweller on Thu Jun 10, 2010 9:56 am, edited 1 time in total.

fogdweller wrote:In most cases if nat all there will be an intermediate point, and this would be another consideration to the 6 CeCe listed. If they check after 6 months or after 2 years it would make a difference to deciding if you want to volunteer.

Interesting, I did not know that was how it worked!

#7) Is there a set intermediate point, where they'd end the study and offer the treatment to all if it has proven itself, and if so, how far out is it?

Fogdweller, it is helpful to hear your point of view, thank you...

"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition

“Let's talk for a moment on double-blinded testing.
I think it is all fake - I'll explain.” – good idea Leonard.

I have been wondering about this too. When I was first diagnosed I expected my neuro to offer me crabs so I looked up the NICE advice on them read some testimonials which was enough to put me off. I then just forgot about the subject. But following the recent newspaper reports about the UK scheme I looked at some studies this week that were cited in the NICE advice. I think these were the original studies published by the drug companies.

Almost all of them were imperfectly blinded by substantial amounts. I think one reported 80% of the treatment group knew they were on treatment. If I remember right none had controls matched for sex or age. One even had 70% females but no information about how they were distributed between the groups. I had expected these studies to be whiter than white since so many neuros bang on about the importance of placebo effects and controls.

Like you, I am beginning to wonder whether it is only important to include controls because you will be criticised if you don’t but that they don’t really think it is important.

fogdweller wrote:This is true, but in most studies there is an intermediate analysis point where the statisticians look at the data and tell the researchers one of three things...(1) either to stop the trial early and offer the treatment to everyone, the end effect has already been established, or (2) keep on with the study, it may or may not find statistically significant results, or (3) stop the study, no matter how good the final group is, it will not be enough to establish statistical significance.

Ive been on this forum long enough to think I am just spinning my wheels. It seems like nothing is changing. Freedman's ofice tells somebody if they had CCSVI their face would be purple (sounds a bit like Dr. Rose).

VERY weary of all this money grubbing. Very weary of Doctors who feel it is their job to be as mean-spirited as they can. Very weary of hearing of more MS deaths. Do you ever just wish you could do *something* that would really make a difference?

AMcG wrote:Almost all of them were imperfectly blinded by substantial amounts. I think one reported 80% of the treatment group knew they were on treatment. If I remember right none had controls matched for sex or age. One even had 70% females but no information about how they were distributed between the groups. I had expected these studies to be whiter than white since so many neuros bang on about the importance of placebo effects and controls.

Like you, I am beginning to wonder whether it is only important to include controls because you will be criticised if you don’t but that they don’t really think it is important.

I really wish I could trust these people more.

I agree, in the end it is all a matter of trust.
In this case, first and above all of the system.
But the system is sick, the culture of double-blinded trials is all pervasive, without even a critical note as to whether this is indeed the right thing for this case or these circumstances.
It is like sheep, they all run after the other, almost blind eye, obsessed with what they have learned and used for decades.
It is exactly the same culture that resists ccsvi and delays testing and treatments.
I have said it here before: this matter needs governance with the big G.

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